Recent CDMO marketing extolling “the only end-to-end services" hasn’t been universally well received by the biopharma professionals it is targeting. Might we start questioning how truthful all CDMO marketing is as a result? That wouldn’t be good for the drug development and manufacturing outsourcing industry.
Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.
It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.
Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.
While providing site training at an Investigator Meeting recently, I came across some interesting comments from sites that were not familiar with using eDiaries or tablets to capture PRO or ClinRO data. By Jane Carter, Program Manager, CRF Health
This protocol was developed to validate the performance of the Thermo Scientific Nunc High Density Cell Factory System (HDCF) for the culturing of MRC-5 cells.
During the last few weeks I had the opportunity to speak with three experienced and successful business development professionals in the pharmaceutical contract manufacturing arena. They asked to remain anonymous, so I will simply refer to them as Hu, Himani, and Henry. What I got from these discussions with three individuals from three different countries was contrasting views on outsourcing and the future direction of the contract research and manufacturing industry. You can look at these as different world views, or to put it more accurately, different regional views.
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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
There is no shortage of guidance for conducting extractables and leachables studies. The trick is aligning standards that overlap.
Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?
Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
